Although biomarkers such as prostate-specific antigen (PSA), have been known and used for decades to attempt to guide prognostic and therapeutic decisions, the recent revolution in molecular biology, with the rise of high-throughput sequencing and increased molecular characterization of tumor tissue has led to an exponential increase in attempts to measure and target aberrant pathways at the molecular level.
In the field of cancer research and care, the concept of precision medicine-prevention and treatment strategies that take individual variability into account-hinges on the development of valid biomarkers interrogating key aberrant pathways potentially targetable with molecular targeted or immunologic therapies ( 1). The Precision Medicine Initiative unveiled in January 2015, included an investment of $70 million to the National Cancer Institute (NCI), to “scale up efforts to identify genomic drivers in cancer and apply that knowledge in the development of more effective approaches to cancer treatment” ( 1). Keywords: Cancer biomarker drug response biomarker prognosis companion biomarker We also discuss regulatory issues and future perspectives in the era of big data analysis and precision medicine. In this review we summarize the steps of biomarker development, highlight key issues in successful validation and implementation, and overview representative examples in the oncology field. However, there is still a large gap between initial biomarker discovery studies and their clinical translation due to the challenges in the process of cancer biomarker development. Genome-based prognostic biomarkers are also available for several cancer types for potential incorporation into clinical prognostic staging systems or practice guidelines. Single gene/protein or multi-gene “signature”-based assays have been introduced to measure specific molecular pathway deregulations that guide therapeutic decision-making as predictive biomarkers. Abstract: With the emergence of genomic profiling technologies and selective molecular targeted therapies, biomarkers play an increasingly important role in the clinical management of cancer patients.
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